NEW! Principal Medical Affairs Biostatistician

Cytel; Denver (CO); On-site; USD 140,000 - 190,000; Full time

Job summary

Cytel is seeking an experienced Principal Biostatistician to lead statistics for Phase I–IV studies across our client region, embedded with a pharmaceutical partner. You’ll design studies, write SAPs, and guide analyses in Medical Affairs while collaborating with Regulatory, Publications, and Epidemiology teams.

You will contribute to DSURs and briefing documents, oversee eCRF design, and support publications. Strong SAS/R/CDISC expertise and ICH GCP knowledge are essential.

Qualifications

• PhD in Biostatistics or MS with 8+ years pharma biostatistics experience.
• Excellent written and oral communication and presentation skills.
• Extensive SAS programming experience.
• Experience with data analysis in clinical studies databases.
• Experience with post-approval observational and clinical studies.
• Understanding of ICH GCP and industry practices.
• Proficiency in R and other statistical software.
• Experience with CDISC SDTM/ADaM/CDASH.

Responsibilities

• Collaborates with Medical Affairs to design post-approval studies.
• Writes the statistical sections of study protocols.
• Contributes to or prepares statistical analysis plans.
• Collaborates with Data Management on eCRF design.
• Provides statistical guidance on ongoing studies.
• Coordinate with Statistical Programming for analysis of trials, registries and observational data.
• Contributes to regulatory documents and scientific articles.
• Participates in meetings to support Biostatistics and Medical Affairs.

Skills

Statistical programming

SAS programming

R programming

CDISC SDTM/ADaM

Clinical data analysis

Data management collaboration

Communication skills

Education

PhD in Biostatistics

MS in Biostatistics

Tools

SAS

R

CDISC

Job description

Who Are You?

An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is but always push clinical development forward to what it could be. You motivate others to do the same.

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview:

As Medical Affairs Biostatistician, you are responsible for statistical activities in support of Medical Affairs, including contributing to post approval study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study data, and conducting ad hoc and exploratory analyses. You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development. Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation.

• Collaborates with Medical Affairs (Medical Research and Value, Evidence & Strategy), Medical Communications and Publications, Epidemiology and Regulatory to design post approval studies.


• Writes the statistical sections of study protocols, while consulting with internal and external experts.


• Contributes to or prepares statistical analysis plans.


• Collaborates with Data Management and Medical Research on design of eCRFs.


• Provides statistical guidance on conduct of ongoing studies.


• Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs.


• Contributes observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.


• Contributes to scientific articles, summarizing data collected in studies.


• Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.


• Reviews abstracts, manuscripts for publications and presentations.

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

• PhD in Biostatistics, Statistics, or equivalent with at least 5 years pharmaceutical biostatistics experience; or MS with at least 8 years' relevant experience.


• Excellent written and oral communication and presentation skills.


• Extensive experience programming in SAS.


• Extensive experiences working on data analysis with clinical studies database.


• Experience working on post-approval observational and clinical studies.


• Understanding of ICH GCP as well as general knowledge of industry practices and standards.


• Experiences in R programming language and other statistical software.


• Experience with CDISC, including SDTM, ADaM, CDASH.

Cytel Inc. is an Equal Employment / Affi...